The Effect of Intravenous Lidocaine on Pain After Tonsillectomy

NCT01291979 | Unknown Phase 4

• 1 other identifier: ChungAngUH1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy. A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation. Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.

Conditions

Postoperative Pain

Keywords

Pain; Preemptive; Lidocaine; Intravenous; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale 4hour

  Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour.

  post op 4hour

Secondary Outcomes (11)

• visual analogue scale 12 hour

  Post op 12 hour

• visual analogue scale 24hour

  Post op 12 hour

• Visual analogue scale 48hour

  Post Op 48hour

• Opioid consumption 4hour

  Post Op 4hour

• Opioid consumption 24hour

  Post op 24 hour

Study Arms (2)

Intravenous lidocaine injection group

ACTIVE COMPARATOR

Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Drug: Intravenous lidocaine injection

Placebo control group

PLACEBO COMPARATOR

Patients in Group C (placebo control group) received normal saline intravenous injection

Drug: Intravenous normal saline injection

Interventions

Intravenous lidocaine injection DRUG

Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Also known as: IV lidocaine

Intravenous lidocaine injection group

Intravenous normal saline injection DRUG

The patients in Group C (placebo control group) received normal saline intravenous injection

Also known as: IV saline

Placebo control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tonsillectomy

You may not qualify if:

• mental change
• allergy to local anesthetics

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

ChungAng University

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hyun Kang, Ph.D.

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  STUDY CHAIR

• KyungSoo Kim, Ph.D.

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Kang, Ph.D.

CONTACT

82-2-6299-2571; roman00@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 9, 2011

Record last verified: 2011-02

Locations

KR (1)